1. Field of Invention
The present invention relates to treatment and prevention of skin yeast infections such as cutaneous candidiasis.
2. Description of Related Art
Monomer and polymer adhesives are used in both industrial (including household) and medical applications. Included among these adhesives are the 1,1-disubstituted ethylene monomers and polymers, such as the α-cyanoacrylates. Since the discovery of the adhesive properties of such monomers and polymers, they have found wide use due to the speed with which they cure, the strength of the resulting bond formed, and their relative ease of use. These characteristics have made the α-cyanoacrylate adhesives the primary choice for numerous applications such as bonding plastics, rubbers, glass, metals, wood, and, more recently, biological tissues.
It is known that monomeric forms of α-cyanoacrylates are extremely reactive, polymerizing rapidly in the presence of even minute amounts of an initiator, including moisture present in the air or on moist surfaces such as animal (including human) tissue. Monomers of α-cyanoacrylates are anionically polymerizable or free radical polymerizable, or polymerizable by zwitterions or ion pairs to form polymers. Once polymerization has been initiated, the cure rate can be very rapid.
Medical applications of 1,1-disubstituted ethylene adhesive compositions include use as an alternate or an adjunct to surgical sutures and/or staples in wound closure, as well as for covering and protecting surface wounds such as lacerations, abrasions, burns, stomatitis, sores, minor cuts and scrapes, and other wounds. When an adhesive is applied to surfaces to be joined, it is usually applied in its monomeric form, and the resultant polymerization gives rise to the desired adhesive bond.
U.S. Pat. Nos. 5,514,371, 5,514,372, 5,575,997, 5,624,669, and 5,582,834 to Leung et al. disclose the addition of a therapeutic agent in a cyanoacrylate composition. The cyanoacrylate adhesive forms a matrix for the therapeutic agent, with the therapeutic agent being released in vivo over time from the matrix during biodegradation of the polymer.
U.S. Pat. No. 5,762,955 to Smith discloses a treatment for healthy, damaged, diseased, or infected biological tissue by applying a bioadhesive coating in conjunction with a medication. The treatment is directed, in part, to treating external biological tissue that may be affected by harmful afflictions such as bruises, burns, dermatological afflictions, infections, gashes, wounds, herpes sores, canker sores, or intra-oral lesions, and skin cancers such as leukemia. Smith further discloses several medications that may be used including corticosteroids, fluoroouracil, obtundants, anesthetics, antibiotics, fungicides, anti-inflammatory agents, antibacterial agents, antiseptic agents, and other medications or combinations of medications used in processes for healing tissue, promoting or preventing blood clotting, destroying cancer cells, palliative treatments and killing of bacteria or viruses.
U.S. Pat. No. 4,880,416 to Horiuchi et al., discloses a dermal bandage of a pre-formed film-like adhesive material for preventing dermally applied ointments, creams, solutions, powders, etc. from falling off, and for delivering drugs, such as anti-fungal agents, to affected parts of the skin. U.S. Pat. Nos. 5,716,607 and 5,716,608, both to Byram et al., disclose the use of cyanoacrylate adhesives to prevent ionization radiation damage to skin. Such damage is prevented by applying the cyanoacrylate polymer to the skin to be protected. U.S. Pat. No. 5,653,769 to Barkey, Jr., et al., discloses protecting skin areas from irritation due to contact with artificial devices such as prosthetics, bandages and casts by applying a cyanoacrylate polymer to the desired skin areas that otherwise would be prone to ulceration or irritation by the devices.
U.S. Pat. No. 4,287,177 to Nakashima et al. discloses a protective covering material for forming a film or coat on the skin or wound surface, wherein the film may contain an anti-fungal agent that is controllably released when the composition is placed in contact with the skin. U.S. Pat. Nos. 5,684,042; 5,753,699; 5,762,919; 5,783,177; and 5,811,091 to Greff et al. disclose a cyanoacrylate composition with a compatible anti-fungal agent to form an anti-fungal polymeric cyanoacrylate film to be applied on mammalian skin as wound dressings, wound bandages, surgical incise drapes, wound closure materials and the like.
Cutaneous candidiasis, also more commonly and generically referred to as skin yeast infection, is a yeast infection or dermatophytosis of the skin, generally caused by yeast species such as of Candida and Blastomyces, particularly or most commonly by the yeast species of Candida albicans, Candida tropicalis, and Blastomyces dermatitidis. The condition generally includes itching, which can be severe or intense, and skin lesions or rash, generally characterized by enlarging patches, macules or papules, reddened (such as beefy red) and/or raw patches of skin, and where the lesions or rash may also be scaly or have satellite blister-like or pimply-like lesions. The condition generally occurs on areas of skin that are warm and moist, such as around skin folds, in the genital or buttock areas, on the trunk, under the breasts, in the arm pits, and the like, but can occur and/or spread to other skin areas.
As used herein, the term “skin yeast infection” or like terms, unless specifically stated to the contrary, is intended to refer to such skin yeast infection as described above, caused by any yeast species not being limited to the Candida yeast. However, the term is not intended to refer to related yeast infections, such as vaginal yeast infections or oral-based yeast infections, such as that known as oral thrush or oral candidiasis. The term skin yeast infection thus also is not intended to refer to similar skin conditions, such as tinea that is caused by fungal infections.
Physicians commonly prescribe medications in the form of powders, aerosols, liquids or creams for the treatment of skin yeast infections. Such medications are also commonly obtained by individuals “over-the-counter” for treatment of the same skin condition. The source of the affliction can often be a matter of personal health and hygiene, can be related to other health conditions, and can be a public safety and health concern. For example, skin yeast infections can generally occur directly from the presence of the yeast on the body, particularly in dead skin and nails or in the warm, moist areas of the body. Skin yeast infections can also arise based on other bodily conditions. For example, skin yeast infections can be more prevalent in women during pregnancy, when the body is undergoing hormonal changes, or in patients with decreased immune system function, such as those with AIDS. From a public health and safety concern, the occurrence and transmission of skin yeast infections is higher in public areas such as locker rooms, public showers or pools, sports facilities, and the like, where direct contact with an infected individual or his or her clothing or other articles is increased.
As described above, often the condition occurs on the skin areas of the body that are warm and moist, such as around skin folds, in the genital or buttock areas, on the trunk, under the breasts, in the arm pits, and the like. These areas of skin typically are prone to higher levels of moisture, and also come into frequent frictional contact with a patient's clothing or with other skin surfaces. As a result of this frictional contact, as well as contact with clothing and the like, topically applied medications can be more easily removed from the affected areas of a patient's skin. Moreover, the topically applied medications are more prone to the affects of moisture that is present at the affected area of skin. These difficulties mean that treatment is significantly reduced, because the medication is not held in place for a sufficient time. As a result, the efficacy of the treatment is significantly reduced, and patients must frequently reapply medications so that the affected area receives proper treatment. Furthermore, the inconvenience of bandages due to constant or frequent movement and flexing of the skin, the small surface area usually involved, friction and moisture, make bandages impractical for minimizing frictional contact that occurs at the affected areas of a patient's skin, as well as impractical as a means to hold the medication in place for longer periods of time.
In addition, conventional treatment regimens for skin yeast infections continue to pose significant public health and safety concerns. Because conventional treatments have the above-described problems of being easily removed from the afflicted skin and being susceptible to moisture, there is a much greater chance that the skin yeast infection can be spread. This spread of the yeast can be either to other parts of the same patient's body, or to other individuals such as through direct contact with the individual, direct contact with the individuals clothing or other articles, or even indirectly through other means such as shower and pool surfaces or the like.
Despite the known use of adhesives, such as described above, such adhesives have not been used in the treatment of skin yeast infections. Instead, the majority of skin yeast infection treatments currently on the market include topically applied medications that have the problems of being easily removed from the application site, being prone to moisture effects, and resulting in higher spread or transmission rates. Therefore, there is a need for an alternative skin yeast infection treatment that remains at the application site for longer periods, that reduces the spread or transmission of the skin yeast infection, and that provides fast, effective relief from the symptoms of skin yeast infection.